KARL STORZ ICG Imaging System with RUBINA® Lens

The KARL STORZ ICG Imaging System with RUBINA Lens is a surgical imaging device that provides real-time visible light and near-infrared fluorescence imaging using indocyanine green (ICG) dye. It is intended for minimally invasive surgery including assessment of blood flow and tissue perfusion, biliary duct visualization, cranial neurosurgery, and lymphatic system visualization in adults and pediatric patients. The RUBINA Lens specifically offers wide-angle visualization for plastic, reconstructive, and breast surgical procedures.

The RUBINA Lens features a 90° direction of view with wide-angle optical design, 18 cm optimal working distance, 32.4°±3° field of view, and dual 2-chip CMOS sensors (one for white light, one for NIR) at 3840×2160p resolution. It provides 2D imaging with selectable display modes (overlay, intensity map, monochromatic) and can be handheld or mounted to a holding arm. The system integrates previously cleared KARL STORZ components including IMAGE1 S camera head, camera control unit, light source, and fiber cables.

ISO 14971:2019 (risk), IEC 62366-1:2015+Amd.1:2020 (usability), IEC 62471:2006 (photobiological safety), IEC 60601-1 and IEC 60601-2-18 3rd Edition (electrical safety/EMC), AAMI TIR12:2020, ANSI/AAMI standards for reprocessing (ST8, ST77, ST98), ISO 11737 and ISO 17665 (sterilization validation), and ASTM F3208-20.

Substantial equivalence is established through comparative bench testing demonstrating the RUBINA Lens meets all design specifications and has similar technological characteristics and operating principles to predicate devices KARL STORZ ICG Imaging System (K233333) and SPY-PHI System (K230727). The device has the same intended use for fluorescence-guided visualization and assessment, and differences in technology do not raise new safety or effectiveness questions. Comprehensive non-clinical testing including optical performance, NIR/ICG imaging, and safety evaluations adequately demonstrates equivalent performance.